Novo Nordisk faces shareholder lawsuit over CagriSema trial disclosures

• Novo Nordisk shareholders allege the company misled investors about a key clinical trial for its next-generation weight-loss drug CagriSema.
• A U.S. judge on Tuesday allowed parts of that lawsuit to move forward.
• Novo has viewed CagriSema as an important next step in its obesity pipeline as competition in the GLP-1 drug market has intensified.

A federal judge on Tuesday allowed parts of that lawsuit to move forward, finding that investors had plausibly alleged that some statements about CagriSema's tolerability and the design of the late-stage trial may have been misleading.

The ruling does not determine that Novo committed securities fraud. Instead, it means the case can proceed into the next stage, where investors can seek evidence supporting their claims.

A Novo Nordisk spokesperson said the company "believes that the allegations against it are meritless," and intends to vigorously defend against them.

It comes as Novo works to boost investor confidence in its obesity business amid mounting competition from Eli Lilly and as it bets heavily on its next generation of weight-loss treatments.

Here's what happened, what the lawsuit alleges, and why CagriSema has become so important to Novo's future.

What Investors Allege

The case centers on CagriSema, an experimental weekly injection that combines semaglutide — the active ingredient in Wegovy and Ozempic — with cagrilintide, which mimics the hormone amylin.

When Novo released CagriSema topline results in December 2024, investors had widely expected the treatment to produce average weight loss of roughly 25%. Instead, the company reported average weight loss of about 20.4% in practice, sending the stock sharply lower.

Shareholders argue they were not adequately informed before those results that the REDEFINE-1 study used a flexible dosing approach that allowed participants to adjust their doses during the study, rather than requiring everyone to escalate to the maximum level. Only 57% of participants ultimately reached the highest dose.

Investors also allege that Novo gave the impression that the Phase 3 REDEFINE-1 trial would follow a dosing approach similar to earlier trials, including a fixed maintenance dose of 2.4 milligrams of semaglutide combined with 2.4 milligrams of cagrilintide.

Investors argue that the disclosure changed how the market understood the trial results, particularly around how well patients tolerated the treatment at the highest dose.

The distinction matters because the court noted that the extent to which patients can remain on a treatment at the intended dose, or drug tolerability, is a key issue for obesity medicines.

"Clinical trials are complicated and nuanced, and investor calls are not scientific conferences," Judge Robert Kirsch wrote in a 56-page opinion. But he added that pharmaceutical companies cannot mischaracterize or omit important aspects of clinical trials in a misleading way.

Novo has denied wrongdoing.

Following the December announcement, Novo's American depositary receipts fell $18.15 per share, or 17.83%, in a single day, with more than 53 million shares traded, according to the ruling. Copenhagen-listed shares dropped 20.7%.

What the Judge Decided

The judge rejected most of the shareholders' allegations, finding that investors had not sufficiently shown that many of the company's statements about CagriSema's weight-loss potential, future trials or other issues were actionable under securities law.

But he allowed claims related to CagriSema's tolerability and REDEFINE-1's clinical protocols to continue.

The court found that investors had plausibly alleged that certain statements about the trial design could have been misleading. Those included statements describing REDEFINE-1 as using a fixed-dose combination and comments from Martin Holst Lange, Novo's former executive vice president of development and current chief scientific officer, about the drug's tolerability profile and dosing approach.

The judge also found that investors had sufficiently alleged the required level of intent for claims involving Lange.

The court pointed to allegations that Lange had been presented to investors as a key executive responsible for answering questions about Novo's clinical trial design and outcomes.

The ruling does not decide whether those allegations are true. It only determines that the claims can proceed to the next stage of litigation.